BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALLURA XPER FD20 BIPLANE

    MDR report key: 6807552 · Received August 21, 2017

    Report

    Report Number
    3003768277-2017-00074
    Event Type
    Injury
    Date Received
    August 21, 2017
    Date of Event
    August 8, 2017
    Report Date
    August 10, 2017
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    OWB
    PMA / PMN Number
    K033737
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PHILIPS FIELD SERVICE ENGINEER (FSE) CONCLUDED THAT THE CUSTOMER USED THE SYSTEM WITH A SPECTRAL FILTER DEFECT. PHILIPS ANALYZED THE LOG FILES AND FOUND THAT DURING SYSTEM STARTUP THE ERROR "SPECTRAL FILTER DEFECT" WAS RECORDED IN THE ERROR LOGGING. THE LOG FILES CONFIRMED THAT DURING THE DAY, USER MESSAGES APPEARED, WARNING THE USER ABOUT THE SPECTRAL FILTER DEFECT. BECAUSE OF THIS DEFECT THE SYSTEM DOESN'T KNOW WHICH SPECTRAL FILTER IS BEING USED. AS A RESULT, THE SYSTEM CALCULATES THE RECEIVED PATIENT DOSE IN THE WORST CASE SCENARIO (WITHOUT A FILTER BEING PRESENT) WHICH IS 5.58 GY. THE ACTUAL RECEIVED PATIENT DOSE IS UNKNOWN, BUT DEPENDING ON WHICH FILTER WAS IN THE BEAM AT THE TIME OF THE EVENT, IT CAN BE SIGNIFICANTLY LOWER AS DISPLAYED. THE SPECTRAL FILTER DEFECT IS SOLVED BY REPLACING THE NICOL V3 CV FD COLLIMATOR WITH THE ACTUAL COLLIMATOR. THE SYSTEM IS NOW WORKING AS INTENDED AND SINCE THEN, NO SIMILAR ISSUES HAVE BEEN REPORTED BY THE CUSTOMER. BASED ON TRENDING ANALYSIS THERE IS NO EXCEPTIONAL REPLACEMENT RATE FOR THIS ITEM, THEREFORE NO FURTHER ACTION WILL BE TAKEN BY PHILIPS.

    Additional Manufacturer Narrative · 1

    WHEN THE INVESTIGATION HAS BEEN COMPLETED PHILIPS WILL INFORM THE FDA.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM THE CUSTOMER IN WHICH IT WAS STATED THAT THE PATIENT DOSE INCREASED DUE TO A SPECTRAL FILTER DEFECT IN THE COLLIMATOR. THE PATIENT RECEIVED A TOTAL AIR KERMA BY THE FRONTAL PLANE OF 5.587 GY AND A TOTAL AIR KERMA WITH THE LATERAL PLANE OF 0.513 GY. A PHILIPS FIELD SERVICE ENGINEER REPLACED THE DEFECTIVE COLLIMATOR. PHILIPS DID NOT RECEIVE FURTHER INFORMATION ABOUT THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588937 ALLURA XPER FD20 BIPLANE INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS HEALTHCARE 722013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other